Severe Asthma, MepolizumaB and Affect: SAMBA Study (SAMBA)
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| ClinicalTrials.gov Identifier: NCT04680611 |
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Recruitment Status :
Recruiting
First Posted : December 23, 2020
Last Update Posted : October 6, 2023
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| Condition or disease | Intervention/treatment |
|---|---|
| Severe Eosinophilic Asthma Psychological Distress Anxiety Depression Psychological Stress Psychological Adjustment Psychological Disorder Psychosocial Problem Psychosocial Stressor Psychological Emotions Emotional Disorder Emotional Dysfunction Emotional Distress Adjustment Adjustment, Emotional Coping Behavior | Other: no study intervention. Patients receive standard clinical care |
This longitudinal observational study will investigate the relationship between patients' asthma control and emotional states and quality of life in patients and their partners where patients have severe eosinophilic asthma. The study will consist of three phases.
Phase 1 In order to extend our pilot study findings and help inform the second stage, investigators will gather Geneva Emotional Wheel (GEW) data from 30 patients currently treated and benefitting from mepolizumab (Nucala®). This data will be compared to the GEW data investigators have already gathered from patients with severe asthma not receiving treatment with mepolizumab (Nucala®). This will provide timely data to support a publication on the GEW findings in severe asthma and allow the description of the impact of mepolizumab (Nucala®). In addition, it will help provide power calculations for a prospective study. Parallel assessment of quality of life (SGRQ and SAQ) and anxiety and depression (HADS) will be made to evaluate the relationship between GEW, SGRQ, SAQ and HADS scores.
Phase 2 In the second stage, investigators will conduct a prospective study of 45 patients newly prescribed mepolizumab (Nucala®) and their partners measuring participants' emotional composition before and 6 and 12 months after starting treatment. The choice of 60 has been based on likely power requirements but was adjusted to 45 based in Phase 1 results. Investigators will also compare the outcomes from the GEW with other standard outcome measures (HADS, ACQ, SGRQ, SAQ, BIPQ), to establish relationship between changes in these measures and changes in GEW scores, to evaluate the utility of the GEW. This will help determine if the GEW reflects changes in asthma control or whether it is reflecting improvements that the current established instruments do not recognise and allow us to quantify the magnitude of that effect. As these patients will receive mepolizumab as part of their clinical care for a year, whilst assessment of clinical efficacy is being established, investigators will gather data on oral steroid dependent exacerbations (severe exacerbations) during this year and relate to their historic exacerbation history in the year before. Evaluation will be made as to whether the 6-month improvement in GEW scores predicts impact of mepolizumab on exacerbation reduction over the first year of administration. In addition, improvements in the GEW will be explored in relationship to systemic inflammatory impact, with measures of blood eosinophils and serum inflammatory biomarkers (Olink inflammatory panel) at baseline, 6 months and 1 year.
Phase 3 Finally, in addition, investigators will conduct qualitative research in the form of semi-structured interviews with a sub-set of couples (20 couples or less if no new information emerges from the interviews) to gain a more detailed insight and identify common key aspects in their subjective experiences, quality of life and emotional processes before starting treatment and after being on treatment with mepolizumab for 6 months.
| Study Type : | Observational |
| Estimated Enrollment : | 120 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Biopsychosocial Impact of Mepolizumab in Severe Eosinophilic Asthma on Quantitative and Qualitative Emotional and Affective Outcomes in Patients and Partners |
| Actual Study Start Date : | September 9, 2021 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients with severe eosinophilic asthma Phase 1
Patients with severe eosinophilic asthma on Nucala(R) treatment
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Other: no study intervention. Patients receive standard clinical care
no intervention. observational study
Other Name: no intervention. observational study |
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Patients with severe eosinophilic asthma Phase 2
Patients with severe eosinophilic asthma to start Nucala(R) treatment
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Other: no study intervention. Patients receive standard clinical care
no intervention. observational study
Other Name: no intervention. observational study |
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Partners of patients with severe eosinophilic asthma Phase 2
Partners of patients with severe eosinophilic asthma to start Nucala(R) treatment
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Phase 3: Patients with severe eosinophilic asthma from Phase 2
A sub-group of patients who participate in Phase 2
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Other: no study intervention. Patients receive standard clinical care
no intervention. observational study
Other Name: no intervention. observational study |
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Phase 3: Partners of patients in Phase 3
Partners of the sub-group of patients who participate in Phase 3
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- Change in emotional composition (using the Geneva Emotions Wheel) [ Time Frame: Phase 1: on enrolment. Phase 2: change to one year after start of treatment ]A 20-item self-report questionnaire identifying 20 discrete emotions with positive or negative valence. The intensity of each emotion can be marked on a 6-point Likert-type scale. Lower scores indicate lower intensity of emotions, higher scores indicate higher intensity of emotions. Respondents can add free text. Can be used a a variety of applications. The emotion labels used in the study have been modified with input from representatives of the target study population to ensure complete relevance to the study..
- change in affective state (using the Hospital Anxiety and Depression Scale) [ Time Frame: Phase 1: on enrolment. Phase 2: change from baseline to 1 year after start of treatment ]Clinical diagnostic self-report questionnaire to assess psychological distress. Consists of anxiety and depression sub-scales. It consists of seven questions for anxiety and seven questions for depression that are in mixed order in the questionnaire. Each question has four possible answers scored from 0-3. There are separate sub-scale scores for anxiety and depression each with cut-off scores 0-7: normal, 8-10: borderline abnormal and 11-21: abnormal. The HADS is a self-report tool and takes 2-5minutes to complete.
- change in self-reported asthma symptom control (using the Asthma Control Questionnaire) [ Time Frame: Phase 1: on enrolment. Phase 2: change from baseline to 1 year after start of treatment ]6-item clinical questionnaire to establish self-assessed asthma control (questions 1-6) and lung function measured by healthcare professional (item 7). 6 of the questions are patients self-report about their asthma during the previous week regarding symptoms and bronchodilator use. Responses are given on a 7-point scale (0=no impairment, 6= maximum impairment). The ACQ score is the mean of all the questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). In general, patients with a score below 1.0 have adequately controlled asthma and above 1.0 their asthma is not controlled. Patients with a score between 0.75 and 1.25 have borderline of adequate control. The smallest clinically important change is 0.5.
- change in functioning and quality of life (using the St Georges Respiratory Questionnaire) [ Time Frame: Phase 1: on enrolment Phase 2: change from baseline to 1 year after start of treatment ]Clinical questionnaire to assess disease impact on quality of life. QThe questionnaire has two parts. Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over the preceding period (range 1 month to 1 year). Part 2 (Questions 9 to 16) is related to the patients' current state. The Activity score covers functioning related to patients' daily physical activity. The Impacts score relates to psychosocial functioning. Although this component relates partly to physical symptoms, it also correlates quite strongly with exercise performance, breathlessness and disturbances of mood (anxiety and depression), therefore it is the broadest component of the questionnaire, covering the whole range of disturbances that respiratory patients experience in their lives. Scoring is weighted, gihres scores indicate worse outcomes.
- change in asthma-related quality of life (using the Severe Asthma Questionnaire) [ Time Frame: Phase 1: on enrolment Phase 2: change from baseline to 1 year after start of treatment ]Questionnaire assessing the impact of severe asthma and the effects of treatment on patient's self-reported health-related quality of life. The questionnaire produces two scores: the SAQ score is the aggregation of 16 different QoL domains and the SAQ-global score is the figure given on a 100-point scale. Higher scroes indicate higher adverese impact on the responder's life.The scale takes between 3 to 6 minutes to complete, but completion time reduces on subsequent occasions.
- change in illness perception (using the Brief Illness Perception Questionnaire) [ Time Frame: Phase 2: change from basline to 1 year after start of treatment ]Questionnaire assessing the beliefs individuals have about the cause, controllability and impact on them of the illness. Comprises 9 questions. 8 questions use a Likert scale response. Question 9 can be answered by free text about the perceived cause of illness.
- change in Inflammatory panel and chemokines [ Time Frame: Phase 2 only: change from baseline to 1 year after start of treatment ]Olink inflammatory panel and particular chemokines that are comprehensively listed at https://www.olink.com/content/uploads/2019/04/Olink-Inflammation-Validation-Data-v3.0.pdf) will be used to measure markers of systemic inflammation and assess links between affective states and systemic inflammation. In addition, Serum CCl17 and CCL26 will be measured by ELISA as these biomarkers do not feature in the Olink inflammatory panel.
- lived experiences and psychological processes (using Semi-structured interviews) [ Time Frame: Phase 2 only: change from baseline to 1 year after start of treatment ]Interviews to explore participants' quality of life
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
Phase 1:
- Age 18 or over
- Having a diagnosis of severe eosinophilic asthma
- Currently on mepolizumab (Nucala®) treatment
- At least basic command of English
- Giving written informed consent
Phase 2 Patient eligibility Inclusion criteria
- Age 18 or over
- Having a diagnosis of severe eosinophilic asthma
- Scheduled to start mepolizumab (Nucala®) treatment
- At least basic command of English (for sub-study: conversational level of English that does not require a translator)
- Giving written informed consent
- Co-habiting with an intimate partner who is willing to participate in the study
Exclusion criteria
- Participated in Phase 1
- Currently on mepolizumab (Nucala®) treatment
- Major psychiatric disorder currently under treatment
- History of any major psychiatric disorder in the last 5 years, excluding depressive and anxiety disorders that can be included if treatment or change of treatment (including change in dose of medication) has not started within the last 6 months
- Any diagnosed severe comorbid chronic condition that, in the opinion of the patient's asthma physician, might impact on the patient's or partner's affective state (e.g. cancer, diabetes, heart failure, chronic liver disease, chronic kidney disease, autoimmune or neuro-degenerative disease).
- Partners only: diagnosis of severe eosinophilic asthma
- Death of spouse, main informal carer or first-degree family member within the last 3 months
- Current oral corticosteroid maintenance treatment
Partner eligibility Inclusion criteria
- Age 18 or over
- At least basic command of English (for sub-study: conversational level of English that does not require a translator)
- Giving written informed consent
- Partners: Co-habiting with an intimate partner who has severe eosinophilic asthma and is willing to participate in the study
Exclusion criteria
- Participated in Phase 1
- Major psychiatric disorder currently under treatment
- Participant self-reported history of any major psychiatric disorder in the last 5 years, excluding depressive and anxiety disorders that can be included if treatment or change of treatment (including change in dose of medication) has not started within the last 6 months.
- Participant self-reported any diagnosed severe comorbid chronic condition that, in the opinion of the patient's asthma physician, might impact on the patient's or partner's affective state (e.g. cancer, diabetes, heart failure, chronic liver disease, chronic kidney disease, autoimmune or neuro-degenerative disease).
- Diagnosis of severe eosinophilic asthma
- Death of spouse, main informal carer or first-degree family member within the last 3 months
- Current oral corticosteroid maintenance treatment
Phase 3:
Phase 3 is a qualitative study on a sample of couples from Phase 2 therefore the same exclusion criteria will apply as in Phase 2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680611
| United Kingdom | |
| Department of Respiratory Medicine, Aberdeen Royal Infirmary | Recruiting |
| Aberdeen, Grampian, United Kingdom, AB25 2ZN | |
| Contact: David Miller, PhD 01224 438461 david.miller@nhs.scot | |
| Judit Varkonyi-Sepp | Recruiting |
| Southampton, Hampshire, United Kingdom, SO166YD | |
| Contact: Judit Varkonyi-Sepp, Chief Investigator +44 023 8120 6315 j.varkonyi-sepp@soton.ac.uk | |
| Principal Investigator: Anna Freeman, Dr | |
| Hull University Teaching Hospitals NHS Trust | Recruiting |
| Hull, Yorkshire, United Kingdom, HU16 5JQ | |
| Contact: Shoaib Faruqi, MD 01482 624009 shoaib.faruqi1@nhs.net | |
| Pinderfields Hospital | Recruiting |
| Wakefield, Yorkshire, United Kingdom, WF1 4DG | |
| Contact: James McCreanor, MD 01924 542895 james.mccreanor@midyorks.nhs.uk | |
| Glasgow Gartnavel General Hospital | Recruiting |
| Glasgow, United Kingdom, G12 0YN | |
| Contact: Rekha Chaudhuri, Professor 0141 211 3000 Rekha.Chaudhuri@ggc.scot.nhs.uk | |
| Portsmouth Hospitals NHS Trust | Recruiting |
| Portsmouth, United Kingdom | |
| Contact: Thomas Brown, Dr 004402392286000 Thomas.Brown@porthosp.nhs.uk | |
| Responsible Party: | University Hospital Southampton NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT04680611 |
| Other Study ID Numbers: |
RHM MED1740 |
| First Posted: | December 23, 2020 Key Record Dates |
| Last Update Posted: | October 6, 2023 |
| Last Verified: | October 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Only anonymised and aggregate data will be shared |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Asthma Pulmonary Eosinophilia Stress, Psychological Mental Disorders Behavioral Symptoms Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Hypereosinophilic Syndrome Eosinophilia Leukocyte Disorders Hematologic Diseases |